· Mar 27, 2024

EU HTA: HAS "committed" to "a coherent and useful system"

The French National Authority for Health (HAS) is actively preparing for the European Common Assessment of Medicinal Products and Medical Devices to come into force at the beginning of 2025. This initiative, resulting from the regulation on the joint assessment of health technologies, will be implemented progressively, with different deadlines for different product categories. A specific governance structure has been set up, comprising a coordination group and four sub-groups working on various aspects of the assessment. A committee known as "la comitologie" is also responsible for assisting the European Commission in drafting the implementing acts required to implement the regulations. HAS plays a key role in these discussions, being represented at all levels of European governance.

The common clinical evaluation process for medicinal products is based on evaluation schemes known as "PICO" (Population, Intervention, Comparators and Clinical Outcomes). Manufacturers will have to structure their dossiers in response to these schemes. Although the definition of comparators may vary from country to country, efforts are being made to keep the number of PICOs to a minimum, while guaranteeing exhaustive and relevant evaluation. HAS expects an additional workload in the evaluation of healthcare products, and stresses the need for close coordination with the European Medicines Agency (EMA). In addition, the planned joint scientific consultation aims to harmonize assessment agencies' expectations in terms of clinical data generation. Although structural differences exist between the healthcare systems of EU member states, significant progress has already been made in harmonizing evaluation methodologies and procedures.